Monday

This is your brain on love

This is your brain on loveWhen you're attracted to someone, is your gray matter talking sense -- or just hooked? Scientists take a rational look.
By Susan BrinkLos Angeles Times Staff WriterJuly 30, 2007
Her front brain is telling her he's trouble. Look at the facts, it says. He's never made a commitment, he drinks too much, he can't hold down a job.
But her middle brain won't listen. Man, it swoons, he looks great in those jeans, his black hair curls onto his forehead so adorably, and when he drags on a cigarette, he's so bad he's good.
His front brain is lecturing, too: She's flirting with every guy in the place, and she can drink even you under the table, it says. His mid-brain is unresponsive, distracted by her legs, her blouse and her come-hither stare.
"What could you be thinking?" their front brains demand.
Their middle brains, each on a quest for reward, pay no heed.
Alas, when it comes to choosing mates, smart neurons can make dumb choices. Sure, if the brain's owner is in her 40s and has been around the block a few times, she might grab her bag and scram. If the guy has reached seasoned middle age, he might think twice about that cleavage-baring temptress. Wisdom -- at least a little -- does come with experience.
But if the objects of desire are in their 20s, all bets are off. A lot will depend on the influence of Mom and Dad's marriage, the gossip and urgings of friends, and whether life experience has convinced these two brains that what they're looking at is attractive. She just might sidle over to Mr. Wrong and bat her eyes. And he could well give in to temptation.
And so the dance of attraction, infatuation and ultimately love begins.
It's a dance that holds many mysteries, to psychologists as well as to the willing participants. Science is just beginning to parse the inner workings of the brain in love, examining the blissful or ruinous fall from a medley of perspectives: neural systems, chemical messengers and the biology of reward.
It was only in 2000 that two London scientists selected 70 people, all in the early sizzle of love, and rolled them into the giant cylinder of a functional magnetic resonance imaging scanner, or fMRI. The images they got are thought to be science's first pictures of the brain in love.
The pictures were a revelation, and others have followed, showing that romantic love is a lot like addiction to alcohol or drugs. The brain is playing a trick, necessary for evolution, by associating something that just happened with pleasure and attributing the feeling to that magnificent specimen right before your eyes.
All animals mate: The most primitive system in the brain, one that even reptiles have, knows it needs to reproduce. Turtles do it but then lay their eggs in the sand and head back to sea, never seeing their mate again.
Human brains are considerably more complicated, with additional neural systems that seek romance, others that want comfort and companionship, and others that are just out for a roll in the hay.
Yet the chemistry between two people isn't just a matter of molecules careening around the brain, dictating feelings like some game of neuro-billiards. Attraction also involves personal history. "Our parents have an effect on us," says Helen Fisher, evolutionary anthropologist at Rutgers University who studies human attraction. "So does the school system, television, timing, mystery."
Every book ever read, and every movie ever wept through, starts charting a course toward the chosen one.
The love dance"Love," that one small word, stands for a hodgepodge of feelings and drives: lust, romance, passion, attachment, commitment and contentment. Studying this brew is made harder because the pathways aren't totally distinct. Lust and romance, for example, have some overlapping biology, even though they are not the same thing.
Similarly, the dance that leads, if we're lucky, to a stable commitment moves through several key steps.
First comes initial attraction, the spark. If someone's going to pick one person out of the billions of opposite-sex humans out there, it's this step that starts things rolling.
Next comes the wild, dizzying infatuation of romance -- a unique magic between two people who can't stop thinking about each other. The brain uses its chemical arsenal to focus our attention on one person, forsaking all others.
"Everyone knows what that feels like. This is one of the great mysteries. It's the love potion No. 9, the click factor, interpersonal chemistry," says Gian Gonzaga, senior research scientist at eHarmony Labs.
The passion lasts at least for a few months, two to four years tops, says relationship researcher Arthur Aron, psychologist at the State University of New York at Stony Brook.
As it fades, something more stable takes over: the steady pair-bonding of what's called companionate love. It's a heartier variety, characterized by tenderness, affection and stability over the long haul. Far less is known about the brains of people celebrating their silver anniversaries or more, but researchers are beginning to recruit such couples to find out.
When Kelly and Robert Iblings of Calabasas had their first face-to-face meeting after a month of corresponding online, all signs of a spark were there. Kelly, 30, recalls thinking "Wow!" Robert, 33, thought Kelly was beautiful. "I love his height," Kelly says of Robert's 6-foot-4 frame. "And those eyes. He's quite handsome. I mean, look at him. He's cute. He's hot."
"She's very cute," Robert says. "And I like the way she laughs."
Their brains' signals were in sync, and it was good.
It probably didn't hurt that they were a little bit nervous about meeting each other.
For years, scientists have known that attraction is more likely to happen when people are aroused, be it through laughter, anxiety or fear. Aron tested that theory in 1974 on the gorgeous but spine-chilling heights of the Capilano Canyon Suspension Bridge in Vancouver, British Columbia -- a 5-foot wide, 450-foot, wobbly, swaying length of wooden slats and wire cable suspended 230 feet above rocks and shallow rapids.
His research team waited as unsuspecting men, between ages 18 and 35 and unaccompanied by women, crossed over. About halfway across the bridge, each man ran into an attractive young woman claiming to be doing research on beautiful places. She asked him a few questions and gave him her phone number in case he had follow-up questions.
The experiment was repeated upriver on a bridge that was wide and sturdy and only 10 feet above a small rivulet. The same attractive coed met the men, brandishing the same questionnaire.
The result? Men crossing the scary bridge rated the woman on the Capilano bridge more attractive. And about half the men who met her called her afterward. Only two of 16 men on the stable bridge called.
Fear got their attention and aroused emotional centers in the brain. "People are more likely to feel aroused in a scary setting," Aron says. "It's pretty simple. You're feeling physiologically aroused, and it's ambiguous why. Then you see an attractive person, and you think, 'Oh, that's why.' "
In a laboratory, Aron tested his arousal theory further by having people run in place for 10 minutes, and compared them with people who didn't run. Those who had exercised were more attracted to good-looking people in photographs than those who had been sedentary.
Any kind of physiological arousal would probably do the trick, Aron concludes from his studies. Couples who ride roller coasters, laugh at a really funny comedian or escape a burning building together get an emotional jolt and could attribute the feeling to the attractiveness of the other.
The forces of attraction are in many ways mysterious, but scientists know certain things. Studies have shown that women prefer men with symmetrical faces and that men like a certain waist-to-hip ratio in their mates. One study even found that women, when they sniffed men's T-shirts, were attracted to certain kinds of body odors.
That initial spark can flash and fade. Or it can become a flame and then a fire, a rush of exhilaration, yearning, hunger and sense of complete union that scientists know as passionate love.
Key to this state of seeing a person as a soul mate instead of a one-night stand is the limbic system, nestled deep within the brain between the neocortex (the region responsible for reason and intellect) and the reptilian brain (responsible for primitive instincts). Altered levels of dopamine, norepinephrine and serotonin -- neurotransmitters also associated with arousal -- wield their influence.
But passionate love is something far stronger than that first sizzle of chemistry. "It's a drive to win life's greatest prize, the right mating partner," Fisher says. It is also, she adds, an addiction.
People in the early throes of passionate love, she says, can think of little else. They describe sleeplessness, loss of appetite, feelings of euphoria, and they're willing to take exceptional risks for the loved one.
Brain areas governing reward, craving, obsession, recklessness and habit all play their part in the trickery.
In an experiment published as a chapter in a 2006 book, "Evolutionary Cognitive Neuroscience," Fisher found 17 people who were in relationships for an average of seven months. She knew they were in love from their answers to what researchers call the Passionate Love Scale. They all said they'd feel deep despair if their lover left, and they yearned to know all there was to know about the loved one.
She put these lovesick, enraptured people in an fMRI to see what areas of their brains got active when they saw a photograph of their beloved ones.
"We found some remarkable things," she said. "We saw activity in the ventral tegmental area and other regions of the brain's reward system associated with motivation, elation and focused attention." It's the same part of the brain that presumably is active when a smoker reaches for a cigarette or when gamblers think they're going to win the lottery. No wonder it's as hard to say no to the feeling of romantic arousal as it would be to say no to a windfall in the millions. The brain has seen what it wants, and it's going to get it.
"At that point, you really wouldn't notice if he had three heads," Fisher says. "Or you'd notice, but you'd choose to overlook it."
Other studies also suggest that the brain in the first throes of love is much like a brain on drugs.
Lucy Brown, professor of neuroscience at the Albert Einstein College of Medicine, has also taken fMRI images of people in the early days of a new love. In a study reported in the July 2005, Journal of Neurophysiology, she too found key activity in the ventral tegmental area. "That's the area that's also active when a cocaine addict gets an IV injection of cocaine," Brown says. "It's not a craving. It's a high."
You see someone, you click, and you're euphoric. And in response, your ventral tegmental area uses chemical messengers such as dopamine, serotonin and oxytocin to send signals racing to a part of the brain called the nucleus accumbens with the good news, telling it to start craving.
"The other person becomes a goal in your life," Brown says. He or she becomes a goal you might die without and would pack up and move across the country for. That one person begins to stand out as the one and only.
Biologically, the cravings and pleasure unleashed are as strong as any drug. Surely such a goal is worth taking risks for, and other alterations in the brain help ensure that the lovelorn will do just that. Certain regions, scientists have found, are being deactivated, such as within the amygdala, associated with fear. "That's why you can do such insane things when you're in love," Fisher says. "You would never otherwise dream of driving across the country in 13 hours, but for love, you would."
Sooner or later, excited brain messages reach the caudate nucleus, a dopamine-rich area where unconscious habits and skills, such as the ability to ride a bike, are stored.
The attraction signal turns the love object into a habit, and then an obsession. According to a 1999 study in the journal Psychological Medicine, people newly in love have serotonin levels 40% lower than normal people do -- just like people with obsessive-compulsive disorders.
Experiments in other mammals add to the human chemical findings. Female prairie voles, for example, develop a distinct preference for a specific male after mating, and the preference is associated with a 50% increase in dopamine in the nucleus accumbens.
But when the monogamous vole is injected with a dopamine antagonist, blocking the activity of the chemical, she'll readily dump her partner for another.
Using their headsKelly and Robert Iblings, now married for nine months, are fascinated by all this talk of nucleus accumbens, addiction and primitive mating instincts. Sure, they admit, they found each other attractive. But they were also making use of their front brains' sharp thinking skills. They were remembering painful past lessons and looking for signs of compatibility.
They had each survived an earlier, failed engagement, and they knew what they were looking for this time around. They were listening to their front brains as they told them to look for compatibility, stability, shared values and commitment.
From their first e-mail exchanges through eHarmony, an Internet dating service, the Iblings each felt they had found a unique mate. She liked to travel. So did he. They both love books and learning, have similar religious beliefs and come from loving, intact families. She no sooner sent an e-mail telling him about an exhibit she saw on a business trip to New York than he sent a message back telling her he knew of the exhibit because he had bought a book on it the day before.
Coincidence, or soul mate?
The front brain certainly gets involved as it ponders all of life's experiences and past mistakes, researchers say -- but not just the front brain. The nucleus accumbens, virtual swamp of dopamine that it is, is also holder of memories. Its quest for reward is influenced by childhood experiences, friends, previous failed engagements or the jerk who cheated on you. The sum of those experiences make some people attracted to a prince or a frog, a princess or a shrew.
And, as it happens, practical matters such as whether a couple both like piña coladas and getting caught in the rain do matter in igniting passionate love.
A research project headed by eHarmony Labs' Gonzaga interviewed 1,200 dating and newlywed couples. The results, reported in the July issue of the Journal of Personality and Social Psychology, found that those who reported similar interests and feelings were more satisfied. "Those who reported chemistry said they felt at ease, relaxed, connected. They knew they had some things in common," he says. "Chemistry is more than just being hot or handsome."
Clearly, in the matters of love, the stars were aligned for the Iblings. When they met, they were ready for each other. But they were also attracted to each other. The chemistry was there. Most relationship researchers think it has to be.
They had what it took to kick-start the relationship with an undeniable urgency, allowing two people to give up the candy store of other choices and commit to each other.
Odds are that in two to four years, this urgency will fade -- and the couple will, if all goes well, settle in for the long haul with companionate love. Such peoples' lives are entwined, as are their property and bank accounts, and they begin to answer questionnaires differently. The rush and the urgency is gone, but they feel committed, emotionally close and stable.
It is the state that many desire, yet it is the least studied. There's a reason for that. Most studies of couples are of college students and young newlyweds.
Brown, however, has recently recruited volunteers for a study of people 40 to 65 who have been together for many years. She'll put them in fMRIs to see where love resides after the urgency fades. "It's unknown, the extent to which these original brain motivations are still active," she says. "Or whether companionate love has turned more cortical, more conscious thinking, more evaluative." Her first volunteers had their brains scanned this month.
The free fall of love's first rush can happen at any age, whether people are 20 or 70, says Elaine Hatfield, psychology professor at the University of Hawaii and relationship researcher.
What differs is that the older people get, the more memories they harbor of joy and trust, rejection and disappointment. And as people learn from experience, the front brain, with its logic and reason, probably gets a greater say.
"When you are young, passion and hope are so strong that's it's almost impossible to stop loving someone," Hatfield says. "After you've been kicked around by life, however, you start to have a dual response to handsome con men: 'Wow!' and 'Arrrrrrgh!'
"It takes not will power but painful experience to make us wise."
Somehow, it all comes together, for better or for worse, the sum total of what's found in the mating dance of the ancient reptilian brain, the passion of the limbic brain and the logic of the neocortex.
Oh, what a ride.

Sunday

2008 GW Topics course begins on Substance Abuse: Prevention, Intervention & Public Health

We had the first meeting of the 2008 course this past week and I have a bright, energetic and diverse group of about 15 students who all seem quite interested in the topic. It was necessary this year to review the basic neurophysiology and pharmacologic priciples, but the group seemed to soak them up readily and now has a good handle on these basics.

This year I did try to post the syllabus on Blackboard, along with a link to the course website and from my Blackboard "Control panel" it looked like I did so. However, since several registered students have not been able to find anything there, I guess it's "back to the drawing board" for me on that. Until I can use Blackboard more reliably, I will have to continue to depend on the website I've been using for the past ten or so years.

This is the first year that I'm also using a blog for the course, or the first time I'm really using a blog for anything. Prior to this, I've been using this space just to post links and items of interest without much in the way of comment. So I'm posting this now and will be very interested to see whether any comments come back from the students, and whether this can develop into a forum for group discussion outside of the class period.

Happy trails,

Alan

Saturday

More Resources for Evidence-based Prevention Programs

Evidence-Based Programs: http://captus.samhsa.gov/national/resources/evidence_based.cfm

CSAP's Model Programs
The SAMHSA Model Programs featured on this site have been rigorously evaluated and have provided solid proof that they have prevented or reduced substance abuse and other related high-risk behaviors. All programs have been reviewed by SAMHSA's National Registry of Evidence-based Programs and Practices (NREPP). This Web site serves as a comprehensive resource for anyone interested in learning about and/or implementing these programs.

CSAP's Northeast CAPT's Database of Effective Prevention Programs
CSAP's Northeast CAPT has created an online, searchable database of effective prevention programs approved by a variety of federal and research agencies. The database allows visitors to compare selection criteria across agencies, review information about the sources those agencies used for their evaluations, and find contact information and descriptions of each intervention.
CSAP's Western CAPT's Best and Promising Practices
This searchable database includes practices that have been shown to be effective in preventing substance abuse and/or the risk factors for substance abuse. Information is provided regarding training, technical assistance and/or materials that facilitate replication of each practice.
U.S. Department of Education's Safe and Drug-Free Schools' Exemplary and Promising Programs
The U.S. Department of Education's Safe and Drug-Free Schools Program has used an expert panel process to identify programs that should be promoted nationally as promising or exemplary. A 15-member Expert Panel oversaw a valid and reliable process for identifying effective school-based programs that promote healthy students and safe, disciplined, and drug-free schools. Using this process, the panel identified 9 exemplary and 33 promising programs.
Office of Juvenile Justice and Delinquency Prevention (OJJDP)
The OJJDP Model Programs Guide is a user-friendly, online portal to scientifically tested and proven programs that address a range of issues across the juvenile justice spectrum. Developed as a tool to support the Title V Community Prevention Grants Program, the Guide has been recently expanded. The Guide now profiles more than 175 prevention and intervention programs and helps communities identify those that best suit their needs. Users can search the Guide's database by program category, target population, risk and protective factors, effectiveness rating, and other parameters. Juvenile justice practitioners are encouraged to take advantage of this helpful resource.
Blueprints for Violence Prevention
The Center for the Study and Prevention of Violence at the University of Colorado at Boulder, with support from the Centers for Disease Control and Prevention and OJJDP, designed and launched a national violence prevention initiative to identify violence prevention programs that are effective. The project has identified 11 model programs that meet a strict scientific standard of program effectiveness. Another 18 programs have been identified as promising. These interventions have been summarized in a series of "blueprints" that describe their theoretical rationales, core components, evaluation designs and results, and practical implementation experiences across multiple sites.

Saturday

2007 Report by Florida Medical Examiners Commission on Drugs Identified in Deceased Persons

News Release
2007 Report by Florida Medical Examiners Commission on Drugs Identified in Deceased Persons
June 12, 2008
Today, the Florida Department of Law Enforcement (FDLE) and the Florida Medical Examiners Commission released the state’s annual report on Drugs Identified in Deceased Persons. The report contains information compiled from autopsies performed by medical examiners across the state in 2007. During that period, there were more than 168,900 deaths in Florida. Of those, 8,620 individuals were found to have died with one or more of the drugs specified in this report in their bodies.

Medical Examiners specifically collected information on these drugs: Ethyl Alcohol, Amphetamines, Methamphetamines, MDMA (Ecstasy), MDA, MDEA, Alprazolam, Diazepam, Flunitrazepam (Rohypnol), other Benzodiazepines, Cannabinoids, Carisoprodol/Meprobamate, Cocaine, Gamma-Hydroxybutyric Acid (GHB), Inhalants, Ketamine, Fentanyl, Heroin, Hydrocodone, Hydromorphone, Meperidine, Methadone, Morphine, Oxycodone, Propoxyphene, Tramadol, and Phencyclidine (PCP).

The report reveals incidences of Amphetamine, MDA, Meperidine, Methamphetamine and all Methylated Amphetamines decreased when compared with 2006. These decreases include cases in which the drug levels were both lethal and non-lethal.

Incidences of Oxycodone, Methadone, Cocaine, Hydrocodone, Alprazolam, Diazepam, Ethyl Alcohol, and Heroin increased in 2007.

The report indicates the three most frequently occurring drugs found in decedents were Ethyl Alcohol (4,179), all Benzodiazepines (2,627), and Cocaine (2,179). The drugs that caused the most deaths were Cocaine, Methadone, all Benzodiazepines (includes Alprazolam), Oxycodone, Ethyl Alcohol, Hydrocodone, and Morphine. Despite the increase in heroin incidences, deaths caused by heroin still remain lower than in 2005 or any prior year.

The report indicates that prescription drugs (Benzodiazepines, Carisoprodol/Meprobamate, and all Opiods, excluding Heroin) continued to be found more often than illicit drugs in both lethal and non-lethal levels.

“This year’s report again reflects that using drugs often leads to fatal consequences,” said FDLE Commissioner Gerald Bailey. “FDLE and our law enforcement partners are working aggressively to take illegal narcotics off the streets, and to educate Florida’s families about the dangers of the abuse of prescription drugs.”

“The rate of deaths caused by prescription drugs is over three times as high as the rate of deaths caused by all illicit drugs combined,” said Director of the Office of Drug Control Bill Janes. “We have not yet implemented a statewide monitoring plan that will help reduce the problem. The monitoring plan is our priority effort, but that is not enough. We are working to increase awareness among our families by focusing our efforts on communities, schools, businesses, churches, and the media. Prescription drugs are not safe and must be secured. Doctors and pharmacists must help law enforcement identify and stop doctor shoppers. We are also looking for ways to curb illegal internet sales. Only through a comprehensive, coordinated strategy will we be able to reverse this tragic, unacceptable trend.”

The Drugs Identified in Deceased Persons by Florida Medical Examiners – 2007 Report is available on the FDLE Web site at http://www.fdle.state.fl.us/
For more information, contact:Bill JanesGovernor’s Office of Drug Control(850) 488-9557
Stephen J. Nelson, M.D.Chairman, Florida Medical Examiners Commission(863) 298-4600
Heather Smith or Kristen PerezluhaFDLE Public Information Office(850) 410-7001

Sunday

Adverse Events Reporting (AER) Act for dietary supplements and other botanicals

Adverse events reporting on botanicals
Article on the Adverse Events Reporting Act for dietary supplements and other botanicals.
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http://abc.herbalgram.org/site/PageServer?pagename=05_01_AER_Labeling_Guidance
FDA Publishes Draft Guidance on Labeling Requirements of AER Act

The US Food and Drug Administration (FDA) announced in the FederalRegister on January 2 that it has issued a draft guidance to assist thedietary supplement industry in complying with the labeling requirementsof the Dietary Supplement and Nonprescription Drug Consumer ProtectionAct ("the AER Act").1 The AER Act requires marketers of dietarysupplements and over-the-counter (OTC) drugs to maintain records of alladverse events reported to the manufacturer and submit reports to theFDA of those incidents meeting the definition of "serious" adverseevents. Comments regarding this draft guidance must be submitted to theFDA by March 3.
According to the draft guidance, dietary supplement labels must includea domestic address or phone number for receiving adverse event reports.The FDA has concluded that this entails either a full US mailing address(complete with street address or post office box number) or a phonenumber with an area code. The FDA further recommends in its guidancethat all dietary supplement labels include a clear, prominent statementinforming consumers that the domestic address or phone number may beused for reporting serious adverse events associated with the product.Although the AER Act went into effect in December of 2007, the FDA hasstated that it intends to exercise enforcement discretion for the newlabeling requirements until January 1, 2009. The requirement to documentadverse events and report serious events to the FDA is currently inforce as of December 22, 2007.
Two prominent industry trade organizations have already expressed someconcerns about the recently issued guidance. The American HerbalProducts Association (AHPA) recently stated in a press release that ithas previously gone on record as arguing that a full US mailing addressis unnecessary for product labels.2 AHPA pointed out that long-standingregulations for foods, drugs, medical devices, and cosmetics have heldthat a company's place of business need not include a street address ifit can be found in a city directory. According to AHPA, FDA explainedthat it has suggested a full mailing address because the agency believesconsumers may choose to not submit a report if they believe it would notbe received due to an incomplete address.
"This is really quite stunning," stated AHPA President Michael McGuffin,according to the AHPA press release.2 "If FDA is stating that theinformation that has been required on food, drug, medical device andcosmetic labeling since 1938 is somehow inadequate to communicate toconsumers, AHPA assumes that FDA would seek a global change in the lawto address any perceived inadequacy and would not single out thisindustry and the OTC drug industry as targets for its hypothesis."
AHPA also objected to FDA's recommendation that companies include astatement about the use of the address or phone number for submittingserious adverse event reports, which AHPA argued "must be seen as awarning statement."
"This was not the intent of the law, and the Senate Committee on Health,Education, Labor and Pensions clearly stated in its official report onthis bill that it 'does not require the label to make any statementother than providing the address or phone number,'" said McGuffin.2
The Council for Responsible Nutrition (CRN) has also recently expresseddisappointment with the guidance document, arguing that it too haspreviously gone on record as opposing such changes in labeling.
"We are dismayed that FDA has introduced these new labelingrequirements, seemingly out of nowhere, particularly because there is nolegislative authority in the statute for these requirements," said SteveMister, president and CEO of CRN (e-mail, January 10, 2008). "It'sparticularly troubling that the agency has chosen to try to impose theserequirements through a draft guidance. These kinds of sweepingdeviations from the stated intent of Congress at least require fullnotice and comment rulemaking."
CRN first learned of FDA officials' interest in changing the labels inthe wake of the passage of the AER law last spring, Mister said.
In a letter sent to Robert E. Brackett, PhD, then-director of the Centerfor Food Safety and Applied Nutrition at the FDA in July of 2007, CRNargued then against both the perceived necessity of a full mailingaddress and of adding a statement about the address and phone number'suse for reporting serious adverse events, for reasons similar to thosegiven by AHPA.3
"The primary purpose of this legislation has always been to assureconsumers that when a company receives a complaint of a serious adverseevent, it will provide that information to FDA. The agency has pastedits own agenda onto the intent of Congress and tried to do so withoutusing the proper administrative procedures," said Mister.
CRN further commented that such label changes would place an undueburden on industry and that manufacturers would need at least 3 years tochange labels on new products being placed on the market.
"We have heard from several of our members that FDA has farunderestimated the financial projections for manufacturers to revisetheir labels," said Mister. "The agency doesn't seem to appreciate thetime and expense involved to make even minor changes to supplementlabeling. Someone, potentially consumers, will have to absorb thesecosts. The agency should reevaluate whether these mandatory changeswould really best serve consumers given these added costs."
The FDA released a prior guidance document in October of 2007 concerningthe submission and recordkeeping of serious adverse events of dietarysupplements and OTC drugs required under the AER Act.4 An articlecovering this guidance document was published in the October issue ofHerbalEGram.5
-Courtney Cavaliere

References1US Food and Drug Administration. Draft guidance for industry: questionsand answers regarding the labeling of dietary supplements as required bythe Dietary Supplement and Nonprescription Drug Consumer Protection Act;availability. 73 Federal Register 197. January 2, 2008. Available at:http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2008_register&position=all&page=197. Accessed January 2, 2008.2FDA issues labeling guidance on SAER law [press release]. SilverSpring, MD: American Herbal Products Association; January 2, 2008.3Mister S. Letter to RE. Brackett (CFSAN, FDA). July 31, 2007.4US Food and Drug Administration. Draft guidance for industry: Questionsand answers regarding adverse event reporting and recordkeeping fordietary supplements as required by the Dietary Supplement andNonprescription Drug Consumer Protection Act; availability. 72 FederalRegister 58313. October 15, 2007. Available at:http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-5074.pdf. Accessed January 7, 2007.5Cavaliere C. FDA publishes draft guidance on serious adverse eventreports. HerbalEGram. October 2007;4(10). Available at:http://abc.herbalgram.org/site/PageServer?pagename=04_10_SAER_Guidance&JServSessionIdr012=xvjgf745d2.app13a. Accessed January 7, 2008.

Smoking predicts suicidality: Findings from a prospective community study

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T2X-4R5G7YS-2&_user=10&_coverDate=11%2F19%2F2007&_alid=673515146&_rdoc=3&_fmt=summary&_orig=search&_cdi=4930&_sort=d&_docanchor=&view=c&_ct=26&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=1f6c6c47f0ffd64e94006aa6f825a709

Research report

Smoking predicts suicidality: Findings from a prospective community study

Thomas Bronischa, , , Michael Höflera, b and Roselind Lieba, c
aMax-Planck-Institute of Psychiatry, Clinic and Clinical Psychology and Epidemiology, Kraepelinstreet 2-10, 80804 Munich, Germany
bTechnical University of Dresden, Clinical Psychology and Psychotherapy, Mommsenstreet 3, 01187 Dresden, Germany
cUniversity of Basel, Epidemiology and Health Psychology, Missionsstrasse 60-62, 4055 Basel, Switzerland
Received 4 July 2007;
revised 10 October 2007;
accepted 10 October 2007.
Available online 19 November 2007.

Abstract
Background
The temporal relationship between smoking and suicidality is not yet clear. This article examines associations between smoking and suicidality and their temporal ordering of onset.
Methods
Baseline and four-year follow-up data were used from the Early Developmental Stages of Psychopathology (EDSP) study, a prospective longitudinal study of adolescents and young adults in Munich, Germany. We assessed smoking (occasional and regular), nicotine dependence, suicidal ideation and suicide attempts using the standardized Munich-Composite International Diagnostic Interview (M-CIDI).
Results
Suicide ideation and suicide attempts were strongly associated with occasional and regular smoking and nicotine dependence at baseline (Odds ratios [OR] range from 1.4 to 16.4). In the prospective analyses, prior occasional, regular smoking and nicotine dependence increased the risk for new onset of suicide ideation (OR range from 1.5 to 2.7) and prior regular smoking and nicotine dependence increased also the risk for onset of suicide attempt(s) (OR range between 3.1 and 4.5). Pre-existing suicidality could not be shown to be associated with subsequent smoking or nicotine dependence. Associations remained stable when participants who fulfilled DSM-IV-criteria for major depression were excluded.
Limitations
The sample is confined to an age cohort of 14 to 24 years. No completed suicides could be observed.
Conclusions
The presence of associations between prior smoking and subsequent suicidality, in concert with the lack of associations between prior suicidality and subsequent smoking suggests the existence of an independent pathway from smoking to suicidality.

Keywords: Suicide attempts; Suicide ideas; Smoking; Community study

Article Outline
1. Introduction
2. Methods
2.1. Design
2.2. Sample
2.3. Diagnostic assessment
2.4. Assessment of suicidality
2.5. Definition of smoking and nicotine dependence
2.6. Statistical analyses
3. Results
3.1. Lifetime prevalence of smoking, nicotine dependence and suicidality at baseline
3.2. Baseline associations between smoking behavior and suicidality
3.3. Is the presence of pre-existing smoking related to the risk for onset of suicide ideation and suicide attempts during the four year prospective follow-up interval?
3.4. Does the presence of pre-existing suicidality predict the risk for onset of smoking during the four year follow-up interval?
4. Discussion
Role of Funding Source
Conflict of interest
Acknowledgements
References
Table 1.
Lifetime prevalence of smoking, nicotine dependence and suicidality at baseline (N = 3021)
The gender difference is significant at p < .05. Asterisks indicate the group with the higher rate. Odds Ratios females versus males are for suicide ideation OR = 1.6; 95% CI = 1.2–2.0; for suicide attempts OR = 2.3; 95% CI = 1.3–4.1; for occasional smoking OR = 0.6; 95% CI = 0.5–0.8; for non-dependent regular smoking OR = 0.9; 95% CI = 0.7–1.2; and for dependent regular smoking OR = 0.9; 95% CI = 0.7–1.2.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Among the N = 2222 respondents with at least occasional use, N = 7 used exclusively tobacco products other than cigarettes.d Smoked cigarettes daily for at least for weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.e Smoked cigarettes daily for at least for weeks in lifetime and fulfill DSM-IV criteria for nicotine dependence.f Excludes suicide attempt(s).

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Table 2.
Baseline associations between smoking status and suicidaliy (N = 3021)
N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval.
The odds ratio is significant p < .05; all odds ratios are controlled for age and gender, alcohol and drug use.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Smoked cigarettes daily for at least four weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.d Smoked cigarettes daily for at least four weeks in lifetime and fulfilled DSM-IV criteria for nicotine dependence.e Excludes suicide attempt(s).

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Table 3.
Association between smoking status baseline and new onset of suicide ideation during the four year follow-up period
N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval:
All analyses were controlled for drug and alcohol use.
The odds ratio is significant p < .05; all odds ratios are controlled for age and gender, alcohol and drug use. N = 23 reported attempts.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Smoked cigarettes daily for at least four weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.d Smoked cigarettes daily for at least four weeks in lifetime and fulfilled DSM-IV criteria for nicotine dependence.

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Table 4.
Associations between smoking status baseline and new onset of suicide attempts during the four year follow-up period
N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval:
All analyses were controlled for suicide ideation at baseline as well as for drug and alcohol use.
The odds ratio is significant p < .05; all odds ratios are controlled for age and gender and alc and drug use.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Smoked cigarettes daily for at least four weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.d Smoked cigarettes daily for at least four weeks in lifetime and fulfilled DSM-IV criteria for nicotine dependence.

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Table 5.
Associations between suicide ideation/attempt(s) at baseline and incident smoking during the four-year follow-up
N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval; all odds ratios are controlled for age and gender and occasional smoking at baseline.

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Journal of Affective DisordersVolume 108, Issues 1-2, May 2008, Pages 135-145

Prometa Drug Court Program Shut Down in Washington State-1/11/2008

Prometa Drug Court Program Shut Down in Wash. January 11, 2008
(http://www.msnbc.msn.com/id/22315918/)

A controversial program in Pierce County, Wash., that referred drug-court offenders to the Prometa treatment regimen has been shut down over concerns that claims of treatment success had been exaggerated, MSNBC reported Jan. 11.For example, program officials didn't account for no-shows and dropouts, and declared patients "drug free" simply if they did not test positive for drugs in the 60 days prior to the end of the program.County officials last year approved an $800,000 treatment program focused on the Prometa drug cocktail of gabapentin, flumazenil and hydroxyzine, which owner Hythiam Inc. has touted as an effective treatment for methamphetamine and cocaine addiction. The Pierce County program has since been widely cited by Hythiam as proof of the program's legitimacy.In the wake of the county's decision to pull the program's funding, Hythiam's stock fell from more than $8 a share in October to $2.75 per share this week. The company licenses doctors to deliver Prometa to patients, who pay up to $15,000 for the treatment. Prometa has not been approved by the Food and Drug Administration as an anti-addiction drug, however. And an audit in Piece County found that Hythiam and the Pierce County Alliance, which administered the drug-court program, had "greatly exaggerated" Prometa's success rate. "It's clear to me that we are much more involved in a marketing scheme … rather than testing real results," said Pierce County Councilman Shawn Bunney.Hythiam and Pierce County Alliance officials disagreed, saying the program's effectiveness will be demonstrated when research is published later this year. "The people who are using it -- the doctors, patients, administrators, and drug court judges -- are seeing an impact with it, so I think the treatment will carry it at the end of the day," said Hythiam Executive Vice President Richard Anderson."There were some who did well with Prometa, though they had some positive (urinalysis) after receiving treatment," said James Boyle, deputy director of the Pierce County Alliance. "The auditors view those folks as not being successful. What we were trying to explain to them was that not every person who enters chemical dependency treatment will be drug free from Day One. … It's a process over time."Among those promoting Prometa on a national level are Andrea Grubb Barthwell, a former deputy director at the Office of National Drug Control Policy, and retired Judge Karen Freeman-Wilson, former CEO of the nonprofit National Association of Drug Court Professionals (NADCP), who both serve on the company's board of directors.However, current NADCP CEO West Huddleston has refused to accept Hythiam as a corporate sponsor until the company produces more scientific evident to support its claims about Prometa.

Notable Quotes from NIDA Notes - Current Background Materials and References

Impacts of Drugs on Neurotransmission Vol. 21, No. 4 (October 2007)
The defining features of drug intoxication and addiction can be traced to disruptions in cell-to-cell signaling. http://www.nida.nih.gov/NIDA_notes/NNvol21N4/Impacts.html

Animal Experiments In Addiction Science Reference Article Vol. 20, No. 5 (April 2006)
To learn how drugs promote abuse and produce addiction, researchers focus on animal behaviors that parallel human drug-related behaviors. http://www.nida.nih.gov/NIDA_notes/NNvol20N5/Reference.html

The Basics of Brain Imaging
http://www.nida.nih.gov/NIDA_Notes/NNVol11N5/Basics.html

Cost-Benefit/Cost-Effectiveness Research of Drug Abuse Prevention: Implications for Programming and Policy NIDA Research Monograph, Number 176 [Printed in 1998] http://www.nida.nih.gov/pdf/monographs/monograph176/download176.html

Ethnic Identification and Cultural Ties May Help Prevent Drug Use http://www.nida.nih.gov/NIDA_Notes/NNVol14N3/Ethnic.html

What Are Club Drugs? http://www.nida.nih.gov/NIDA_Notes/NNVol14N6/WhatAre.html

Nicotine Medication Also Reduces Craving in Cocaine Addicts http://www.nida.nih.gov/NIDA_Notes/NNVol15N1/Nicotine.html

Media Guide: Reliable Background for Science Writers http://www.drugabuse.gov/PDF/MediaGuide.pdf

Risk and Protective Factors in Drug Abuse Prevention http://www.nida.nih.gov/NIDA_Notes/NNVol16N6/Risk.html

Childhood Sex Abuse Increases Risk for Drug Dependence in Adult Women http://www.nida.nih.gov/NIDA_Notes/NNVol17N1/Childhood.html

Users Who Develop Drug Dependence During Each Year After First Use http://www.nida.nih.gov/NIDA_notes/NNVol17N4/BBoard.html

Drug Use Associated With More Opportunities to Use, Higher Rates of Acceptance http://www.nida.nih.gov/NIDA_notes/NNVol17N5/Youths.html

Relationships Matter: Impact of Parental, Peer Factors on Teen, Young Adult Substance Abuse http://www.nida.nih.gov/NIDA_notes/NNVol18N2/Relationships.html

Instrument wizard: http://www.instrumentwizard.com/login.asp

On-Site Psychiatric Treatment Improves Abstinence In Teens With Co-occurring Disorders http://www.nida.nih.gov/NIDA_notes/NNvol20N6/Numbers.html

Drug Sniffing Dog